MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number 8881535762

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: the tip of the luer lock syringe broke off and they were unable to administer iv antibiotics.The medication was prepared by the pharmacy with the tan cap placed over the end of the syringe.The customer stated that this has occurred multiple times and has reported the issue to the pharmacy.

• Brand Name: 35ML SYRINGE LUER LOCK TIP RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11870048
• MDR Text Key: 255364174
• Report Number: 1915484-2021-01248
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 8881535762
• UDI-Public: 8881535762
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881535762
• Device Catalogue Number: 8881535762
• Device Lot Number: 1234567
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1